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Puma’s Neratinib Brings Uncertain Efficacy, Tolerability Concerns To FDA Panel

Executive Summary

Tyrosine kinase inhibitor has an effect in adjuvant breast cancer but ‘there remains some uncertainty regarding the true magnitude of the treatment effect,” FDA reviewers say; given incidence and severity of diarrhea, experts will be asked to consider whether there is a subpopulation with a more favorable risk/benefit profile.

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